Add-on Effect and Safety of Pharmacopuncture Therapy in the Treatment of Patients with Lumbar Spinal Stenosis

Abstract

Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients' Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.

Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial

“…While our research team has previously conducted clinical trials exploring the effectiveness of acupotomy for spinal disorders [14] and pharmacopuncture therapy for LSS [13], we have not encountered any prior clinical trials investigating the combined effect of these two therapies in treating LSS. As such, this study aims to fill this gap in the previous studies and provide valuable insights into the potential synergistic benefits of combining these interventions for patients with LSS.…”

“…Based on previous studies regarding acupotomy [14] and pharmacopuncture therapy [13], this pragmatic, randomized, controlled study was designed to evaluate the overall effectiveness of combined interventions for patients with LSS in a clinical healthcare setting. The eligibility criteria were strictly designed to diagnose degenerative lumbar spinal stenosis.…”

“…A pilot study (n = 40) [13] was conducted to compare the add-on effects of pharmacopuncture treating patients with LSS. The intergroup difference in the mean change of VAS for low back pain between the experimental group (pharmacopuncture therapy + CKMT) and the control group (CKMT) was 12.8 (95% confidence interval 2.2 to 23.3) at the primary endpoint, which is immediately after the 5 weeks treatment.…”

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial

“…Using a published article’s protocol, the study was designed as a pragmatic, randomized, two-parallel, and sex-stratified pilot clinical trial with a 1:1 allocation ratio. 15 This study was approved by the Institutional Review Board of PNUKH (PNUKHIRB 2022-01-002-003) and registered with the Clinical Research Information Service (KCT0007229). We conducted the study in accordance with the Declaration of Helsinki.…”

“…The primary clinical outcome was the mean change in the 100-mm visual analog scale (VAS) 17 score for buttock and leg pain at the primary endpoint (week 5). Secondary outcomes were the clinical relevance, 18 Zurich Claudication Questionnaire (ZCQ), 19 , 20 self-reported walking capacity, 15 Modified–Modified Schober test, 21 EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), 22 , 23 and patients’ global impression of change (PGIC). 24 All outcomes except PGIC were measured at weeks 1, 5, 7, and 13, whereas adverse events (AEs) were documented per visit.…”